Liquid Bandage (2-Octyl-Cyanoacrylate) in Upper Lid Blepharoplasty

This study has been terminated.
(Experimental results were unsatisfatory compared with control.)
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00816270
First received: December 31, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

The aim of this randomized and masked prospective trial is to compare the effectiveness of Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in upper lid blepharoplasty surgery.


Condition Intervention
Blepharoptosis
Procedure: Bilateral Upper eyelid blepharoplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Liquid Bandage(2-Octyl-Cyanoacrylate)and Traditional Suture Closure in Upper Lid Blepharoplasty

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • The overall cosmetic outcome of wound closure technique (experimental: tissue adhesive Octyl-2-cyanoacrylate versus control: traditional nylon suture). [ Time Frame: thirty days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental operatory wound closure with liquid bandage (Johnson & Johnson, Skillman, NJ, USA).
Procedure: Bilateral Upper eyelid blepharoplasty
Bilateral upper lid blepharoplasty was performed on each patient by the same experimented surgeon using a standard technique. One side (right or left upper eyelid) was randomly chosen for experimental closure with liquid bandage and the opposite eyelid served as the control being used a 6/0 nylon continuous sutures.
Other Names:
  • Liquid bandage (Johnson & Johnson, Skillman, NJ, USA)
  • nylon continuous sutures (Ethicon, Norderstedt, Germany)

Detailed Description:

Tissue adhesives have been safely used in a variety of surgical procedures for several years. Butyl-2-cyanoacrylate (Histoacryl) and Octyl-2-cyanoacrylate (Dermabond) was also studied for cosmetic blepharoplasty with satisfactory results. Liquid Bandage (Johnson & Johnson, Skillman, NJ, USA) is a more flexible formulation of octyl-2-cyanoacrylate available in many american drugstores for home use. Animal models shown that this product could accelerate the healing of lamellar wounds and studies in humans have demonstrated its safety and effectiveness as an occlusive protective film over cuts, abrasion and wound surgery. Liquid Bandage was also used as a temporary wound barrier in clear corneal cataract surgery with satisfactory applicability. There is no study in the literature using this device in blepharoplasty yet.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 25 years with diagnosis of dermatochalasis who presented surgical indication of primary blepharoplasty.

Exclusion Criteria:

  • Prior eyelid surgery
  • Concomitant ocular or systemic disease or current use of medications that could interfere in coagulation or wound healing (eg, diabetes mellitus, oral acetyl salicylic acid or corticosteroids)
  • Pregnant female
  • Known allergy to cyanoacrylate
  • Inability to return for follow-up consultations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816270

Locations
Brazil
Department of Ophthalmology of Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Angelino J Cariello, MD Federal University of Sao Paulo
  More Information

Publications:
Veloudios A, Kratky V. Cyanoacrylate Tissue Adhesive in Blepharoplasty. Ophthalm Plastic Reconstr Surg 1996;12(2):89-97. Greene D, Koch RJ, Goode RL. Efficacy of Octyl-2-Cyanoacrylate Tissue Glue in Blepharoplasty. Arch Facial Plast Surg 1999;1:292-6. Davis SC, Eaglstein WH, Cazzaniga AL, Mertz PM. An octyl-2-cyanoacrylate formulation speeds healing of partial-thickness wounds. Dermatol Surg 2001;27:783-8.

Responsible Party: Angelino Julio Cariello, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00816270     History of Changes
Other Study ID Numbers: CEP 1716/07
Study First Received: December 31, 2008
Last Updated: December 31, 2008
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Blepharoptosis
Dermatochalasis
octyl 2-cyanoacrylate
Suture Techniques
Tissue Adhesive

Additional relevant MeSH terms:
Blepharoptosis
Eye Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on October 20, 2014